Jobannonce: Re­gu­la­tory Affairs Com­pli­an­ce Manager

Astellas Pharma A/SRe­gu­la­tory Affairs Com­pli­an­ce Manager

Astellas Pharma A/S

Reporting into the RA lead for the Nordics, this role will focus on the Regulatory compliance activities across the Nordics cluster for assigned products. This will involve the timely preparation, submission, conduct and follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities. This position will provide regulatory guidance to multidisciplinary teams in order to meet regulatory demands (legislation and guidelines) and ensure high quality labelling translation and compliant printed packaging materials of marketed products. Part of the focus of this role will also ensure RA stays updated on relevant EU and local regulations and guidelines. Key activities for this role are noted below:

  • Support implementation locally of new initiatives, management tools or processes ensure that processes, procedures and regulatory files are well documented in up to date

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